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冠状动脉药物洗脱支架临床前研究的审评考虑 被引量：1

The Authorized Considerations on the Pre-clinical Study of Drug-Eluting Coronary Stent System
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摘要 冠状动脉药物洗脱支架产品的研发日益增多,但监管机构并未颁布相关的临床前研究规范,该文对目前该类产品临床前研究的技术审评考虑进行了总结,以进一步为生产企业临床前研究的申报资料准备提供参考。 China Food and Drug Administration didn＇t issue any guideline on the pre-clinical study of drug-eluting coronary stent system, the basic requirement of the authorized administration was summarized to help manufacture prepare the document during the registration process.
作者 程茂波 史新立 贾健雄 苗晶晶 刘威 聂飞龙
机构地区 国家食品药品监督管理总局医疗器械技术审评中心
出处 《中国医疗器械杂志》 CAS 2014年第6期461-462,共2页 Chinese Journal of Medical Instrumentation
关键词 冠状动脉药物洗脱支架 临床前研究 药械组合 注册产品标准 drug-eluting coronary stent system, pre-clinical study, combination products, standard
分类号 R541.4 [医药卫生—心血管疾病]
  • 相关文献

参考文献9

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共引文献158

同被引文献24

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引证文献1

二级引证文献6

中国医疗器械杂志
2014年 第6期

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